EP3492052A1 - Injektor und intrakorneales segment zur behandlung von hornhauterkrankungen - Google Patents

Injektor und intrakorneales segment zur behandlung von hornhauterkrankungen Download PDF

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Publication number
EP3492052A1
EP3492052A1 EP18208901.1A EP18208901A EP3492052A1 EP 3492052 A1 EP3492052 A1 EP 3492052A1 EP 18208901 A EP18208901 A EP 18208901A EP 3492052 A1 EP3492052 A1 EP 3492052A1
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EP
European Patent Office
Prior art keywords
segment
intracorneal
injector
head
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP18208901.1A
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English (en)
French (fr)
Inventor
Roberto Gustavo Albertazzi
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Individual
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Individual
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Publication date
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Publication of EP3492052A1 publication Critical patent/EP3492052A1/de
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/007—Methods or devices for eye surgery
    • A61F9/008—Methods or devices for eye surgery using laser
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/147—Implants to be inserted in the stroma for refractive correction, e.g. ring-like implants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/148—Implantation instruments specially adapted therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/14—Eye parts, e.g. lenses or corneal implants; Artificial eyes
    • A61F2/16—Intraocular lenses
    • A61F2/1662—Instruments for inserting intraocular lenses into the eye
    • A61F2/1664—Instruments for inserting intraocular lenses into the eye for manual insertion during surgery, e.g. forceps-like instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F9/00—Methods or devices for treatment of the eyes; Devices for putting in contact-lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
    • A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
    • A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0048—Eye, e.g. artificial tears
    • A61K9/0051—Ocular inserts, ocular implants

Definitions

  • the present invention belongs to the field of ophthalmological surgery and relates to an applicator instrument for rigid intrastromal inserts for the treatment of corneal ectasias (progressive deformations).
  • Segments or intracorneal inserts have gained a place in recent years for the treatment of ectopic diseases of the cornea for their safety and efficiency but, above all, for the ability to improve vision without correction of these patients. These segments are not usually easy to manipulate manually for their dimensions to be inserted and the instrument that is proposed helps in this field.
  • the treatment consists in placing intracorneal inserts in the form of arc segments within the stroma (the corneal body itself). To install them a channel is created parallel to the corneal surface of about 80% of the corneal thickness or 150 ⁇ m (micrometers) of the corneal endothelium is left.
  • the creation of this channel is usually done with the assistance of a FemtoLaser used for this purpose in ophthalmologic surgery or it can be done with the help of a semicircular spatulas after an incision with a precalibrated scalpel to the desired depth.
  • US Publication No. 2009/137,988 describes techniques and systems for performing optical function by means of a laser.
  • Manipulating the intracorneal segments is not easy due to the tiny size of the implant, the visibility of the implant and the rigidity of its material, apart from the different types of containers that do not always place the insert in its place.
  • the Russian patent ( RU) No. 2,375,025 (Federal Noe G Uchrezhdenie MNT) refers to the effect of rings on the cornea and the effect of keratoconus.
  • US publication ( US) No. 2002/72,673 (Yamamoto) refers to an apparatus for guiding substances or devices towards the Schlemm's canal to relieve ocular pressure in the treatment of glaucoma so that the surgery is minimally invasive.
  • US publication ( US) No. 2016/310417 (Emory University) refers to formulations, systems and methods of administration for injecting drugs or placing ocular tissue in the suprachoroidal space through microneedles.
  • Fig. 1A illustrates a McPherson-Albertazzi type forceps and fig. 1B a Sinskey type tip.
  • One of the most difficult and main objective problems posed by the invention is how to inject a rigid material, as opposed to injecting a liquid or a gel, with an instrument with the dimensions that enter a needle.
  • Another object of the invention is to manufacture an instrument capable of injecting different types of intracorneal segments whatever their parameters such as arc, profile, thickness and diameter are.
  • the injector of the present invention is a rigid material delivery instrument that is used to manually slide the intracorneal segment. It includes a segment container holding inside the preloaded segment, sterile and ready for use. The container is placed in front of a handle to push the insert and contains a kind of sword or modified Sinskey hook, which is used to slide the segment.
  • the handle has the following parts: needle, pointer, body, stop, trigger, spring and cover.
  • the slider head that holds the segment has the following different parts: lancet, lid, selector and the segment or corneal insert itself that it is preloaded in the instrument and injected from the same, without having to touch it with any forceps or other instrument, solving an important problem if, on the contrary, segments with these characteristics had to be manipulated (dimensions, static electricity, etc.).
  • the segment can be placed or delivered at 90° of the head either to the right or the left manually according to the position of a selector mounted on the handle.
  • the base of the injector is designed with three different inclinations of 0°, 17° and 34° depending on the profile of the segment used and preloaded. Thanks to its design, the instrument allows to inject the segments or implants either to the right or to the left of the channel where it will be housed, without touching the segment or the danger that it jumps, because it is fixed and housed inside the instrument preventing any sudden movement as may occur with a forceps.
  • the present invention also teaches to add knurls forming recesses in the outer chord to improve or facilitate the thrust of the instrument without losing the physiological functionality.
  • the segments are injected with the help of the instrument.
  • the segment is introduced through the incision and, once the segment is with its end in the desired place, it is injected with the help of the trigger which, when moved forward, moves the needle, which, through the right-left selector previously selected, is housed in the knurls of the segments to inject the implant into the tissue, either towards the temporal part of the cornea as the nasal portion, up or down, right or left, indistinctly.
  • the sliding part where the implant was housed can be separated from the end of the handle and discarded.
  • the handle that houses the modified Sinskey hook can be resterilized to be reused on other occasions.
  • FIGS 2 and 3A show an intracorneal insert or implant 11 of a rigid material such as medical grade CQ transparent acrylic or PMMA (PolymethylMethacrylate); alternatively, it can be manufactured with Prolene or another plastic material compatible with corneal metabolism.
  • the intracorneal insert 11 has the shape of a circular segment of 135° measuring 0.15 mm in plan, having a constant thickness in the medial plane arc 12, gradually flaring to the inner 13 and outer 14 chords of the segment 11.
  • This insert 11 has an inclination of 0°, i.e. it has no inclination.
  • a similar insert 11' is shown but the inclination 16' is 17° and Figure 3C shows another similar insert 11" with an inclination 16" of 34°.
  • the inserts 11 can have 5; 6 or 7 mm central diameter. The dimensions of the segments are critical with a tolerance of +/-15 ⁇ m (micrometers) to have predictable results. The description so far is applicable to conventional inserts such as those manufactured by Ferrara Ring, Intacs and Keraring wherein the surface of the outer chord is smooth.
  • the conventional segment is modified by a knurling of the outer chord 14 to form small recesses 16 to improve the pushing and implantation capability of the injector 21 described in the following paragraphs.
  • the recesses 16 are about ten and are equidistantly distributed.
  • Figures 4 to 6 show the injector 21 that can be used for implanting the segment 11 of figure 2 in a cornea according to the main object of the present invention. It is a rigid material delivery instrument that is used to manually slide the intracorneal segment 11.
  • the injector 21 consists of two parts: a handle 22 used to push the segment 11 and a head 34 placed in front of a handle 23 and containing the segment 11.
  • the head 34 is disposable: it is discarded once the end where the segment 11 was housed is used.
  • the handle 22 is re-sterilizable for reuse in future occasions.
  • the handle 22 is formed by a needle 26, a pointer 27, a body 28, a stop 29, a trigger 31, a spring 32 and a cover 33.
  • the pointer 27 is the coupling piece with the head 34, which is basically a container 22 that houses the preloaded intracorneal segment 11, sterile and ready for use.
  • the head 34 comprises a segment holding lancet 36, a lid 37, a selector 38 and the corneal segment 11 itself housed within a cavity defined between the segment holding lancet 36 and the lid 37.
  • the interior of the lancet 36 is shaped to retain the corneal segment 11 together with the lid 37.
  • the base of the lancet 36 is designed with three different inclinations of 0° (coplanar), 17° or 34° (actual inclination) according to the profile of the segment used and preloaded.
  • the pointer 27 is coupled to the body 28 of the handle, and inside a needle 26 longitudinally runs forward under the pressure of the spring 32 when the trigger 31 is pulled 31.
  • Behind the corneal segment 11 is the portion of the selector 38 which protrudes by a transverse slot in the lid so that it can be moved from left to right and vice versa.
  • the segment 11 can be placed or delivered at 90° of the head either to the right or the left, depending on the position of the selector 38, that is manually selected.
  • the position of the selector 38 determines if the needle 26 deflects to the left or right when it is pushed forward.
  • the body 28 has a rear protrusion wherein the spring 32 is housed and which penetrates inside the cover 33 to which it is attached.
  • the surgeon moves the trigger 31 forward, moving the needle 26 by placing it in the knurls 16 of the segments 11 to inject the implant into the tissue, either towards the temporal part of the cornea or the nasal portion, upwards or downwards, to the right or left according to the position of the right-left selector 38 previously selected.

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  • Health & Medical Sciences (AREA)
  • Ophthalmology & Optometry (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Cardiology (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Surgery (AREA)
  • Prostheses (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
EP18208901.1A 2017-11-29 2018-11-28 Injektor und intrakorneales segment zur behandlung von hornhauterkrankungen Withdrawn EP3492052A1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
ARP170103326A AR110649A1 (es) 2017-11-29 2017-11-29 Inyector y segmento intracorneal para tratar trastornos corneales

Publications (1)

Publication Number Publication Date
EP3492052A1 true EP3492052A1 (de) 2019-06-05

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EP18208901.1A Withdrawn EP3492052A1 (de) 2017-11-29 2018-11-28 Injektor und intrakorneales segment zur behandlung von hornhauterkrankungen

Country Status (6)

Country Link
US (1) US11090150B2 (de)
EP (1) EP3492052A1 (de)
AR (1) AR110649A1 (de)
BR (1) BR102018074662A2 (de)
CO (1) CO2018012865A1 (de)
MX (1) MX2018014611A (de)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995003747A1 (en) * 1993-08-02 1995-02-09 Keravision, Inc. Segmented pliable intrastromal corneal insert
WO1999030644A1 (en) * 1997-12-18 1999-06-24 Keravision, Inc. Corneal implant introducer
US20020072673A1 (en) 1999-12-10 2002-06-13 Yamamoto Ronald K. Treatment of ocular disease
US20090137988A1 (en) 2007-11-02 2009-05-28 Lensx Lasers, Inc Methods And Apparatus For Improved Post-Operative Ocular Optical Performance
US20090306773A1 (en) 2008-06-04 2009-12-10 Acufocus, Inc. Opaque corneal insert for refractive correction
RU2375025C1 (ru) 2008-10-16 2009-12-10 Федеральное государственное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова Федерального агентства по высокотехнологичной медицинской помощи" Способ формирования роговичного тоннеля для имплантации интракорнеальных сегментов
US20160310417A1 (en) 2013-12-20 2016-10-27 Emory University Formulations and Methods For Targeted Ocular Delivery of Therapeutic Agents
WO2017117689A1 (es) * 2016-01-05 2017-07-13 Fernandez Telleria, Fernando Disposición de segmentos intraestromales

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102013105184B4 (de) * 2013-05-21 2020-02-20 Carl Zeiss Meditec Ag Injektorvorrichtung zum Einführen einer Intraokularlinse in ein Auge sowie Verfahren zum Falten einer Intraokularlinse in einer Injektorvorrichtung
EP3302381A4 (de) * 2015-06-03 2018-09-19 Aquesys, Inc. Ab-externo-platzierung von intraokularem shunt

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1995003747A1 (en) * 1993-08-02 1995-02-09 Keravision, Inc. Segmented pliable intrastromal corneal insert
WO1999030644A1 (en) * 1997-12-18 1999-06-24 Keravision, Inc. Corneal implant introducer
US20020072673A1 (en) 1999-12-10 2002-06-13 Yamamoto Ronald K. Treatment of ocular disease
US20090137988A1 (en) 2007-11-02 2009-05-28 Lensx Lasers, Inc Methods And Apparatus For Improved Post-Operative Ocular Optical Performance
US20090306773A1 (en) 2008-06-04 2009-12-10 Acufocus, Inc. Opaque corneal insert for refractive correction
RU2375025C1 (ru) 2008-10-16 2009-12-10 Федеральное государственное учреждение "Межотраслевой научно-технический комплекс "Микрохирургия глаза" имени академика С.Н. Федорова Федерального агентства по высокотехнологичной медицинской помощи" Способ формирования роговичного тоннеля для имплантации интракорнеальных сегментов
US20160310417A1 (en) 2013-12-20 2016-10-27 Emory University Formulations and Methods For Targeted Ocular Delivery of Therapeutic Agents
WO2017117689A1 (es) * 2016-01-05 2017-07-13 Fernandez Telleria, Fernando Disposición de segmentos intraestromales

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ANONYMOUS: "Chord (geometry) - Wikipedia", 16 April 2020 (2020-04-16), XP055689393, Retrieved from the Internet <URL:https://en.wikipedia.org/wiki/Chord_(geometry)> [retrieved on 20200427] *

Also Published As

Publication number Publication date
MX2018014611A (es) 2019-07-08
US20190159888A1 (en) 2019-05-30
CO2018012865A1 (es) 2018-12-14
BR102018074662A2 (pt) 2019-06-25
AR110649A1 (es) 2019-04-17
US11090150B2 (en) 2021-08-17

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